Adult Asthmatics and Acid Reflux

AstraZeneca1,400 enrolled

Overview

The purpose of this study is to assess the efficacy and safety of Nexium in the treatment of subjects with persistent asthma believed to have acid reflux as a contributory factor to control of their asthma.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

1,400

Conditions

Asthma

Interventions

EsomeprazoleDRUG

40mg twice a day

PlaceboDRUG

40mg twice a day

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Clinical diagnosis of asthma * Forced Expiratory Volume and Peak Expiratory Flow as defined by the protocol * Daily use of inhaled GCS and/or leukotriene pathway modifier for greater than 3 months. * Severe heartburn 3 days/week during the run-in period. Exclusion Criteria: * Subjects with a history of 3 sinus infections treated with antibiotics in the year prior to Visit 1. * Any other significant disease or pathology judged to be clinically significant by the investigator

Outcomes

Primary Outcomes

Effect on asthma symptoms as measured by changes in Peak Expiratory Flow morning & evening, Forced Expiratory Volume and asthma symptom scores

Time frame: 4 weekly

Secondary Outcomes

Safety as assessed by adverse event recording and clinical and laboratory measurements.

Time frame: 4 weekly

Data from ClinicalTrials.gov

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